The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Abbott Quickstart Gamma-glutamytransferase Test.
| Device ID | K913024 |
| 510k Number | K913024 |
| Device Name: | ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G.bentley |
| Correspondent | Anna G.bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-09 |
| Decision Date | 1991-07-26 |